Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method
Overview
- Phase
- Phase 4
- Intervention
- Holter ECG monitor
- Conditions
- Arrhythmia, Cardiac
- Sponsor
- Medical University of Warsaw
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This study evaluates the incidence of cardiac arrhythmias during the perioperative period in patients undergoing open kidney cancer surgery in the lateral position. All the participants will be randomly allocated to receive general (Group G) or combined epidural/general anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM)
Detailed Description
Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They are also a major source of morbidity and mortality. After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete. There is no literature data about their incidence during kidney surgery in the lateral position when the bed is scissored so the legs and head are low. The aim of this study was to define what types of arrhythmias are the most common during kidney cancer surgery, their incidence and whether combining general with epidural anesthesia prevents them. An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study. It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral position, under general or combined anesthesia will be enrolled. A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM). Patients will be randomly allocated (random permuted blocks within strata) to receive general or combined epidural/general anesthesia. The anesthetic technique is standardized. All the data registered by the Holter ECG monitor will be analyzed and compared with the nursery and anesthesia records.
Investigators
Karolina Dobrońska
M.D.
Medical University of Warsaw
Eligibility Criteria
Inclusion Criteria
- •Open renal cell carcinoma surgery, lateral position
- •American Society of Anesthesiologists (ASA) physical grade I-III
- •No history of cardiac arrhythmias
- •Informed consent
Exclusion Criteria
- •Pregnancy and breast feeding
- •Contraindications for epidural anesthesia
- •Laparoscopic or robotic surgery
- •Suspected difficult intubation (ex. fibroscopic)
- •Chest deformations
- •Prior cardiac/thoracic surgery
- •Cardiac insufficiency
- •abnormal ECG before the surgery
Arms & Interventions
General anesthesia (G)
Holter ECG monitor General anesthesia Open kidney cancer surgery
Intervention: Holter ECG monitor
General anesthesia (G)
Holter ECG monitor General anesthesia Open kidney cancer surgery
Intervention: Open kidney cancer surgery
General anesthesia (G)
Holter ECG monitor General anesthesia Open kidney cancer surgery
Intervention: General anesthesia
Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Intervention: Bupivacaine-fentanyl
Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Intervention: Holter ECG monitor
Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Intervention: Open kidney cancer surgery
Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Intervention: General anesthesia
Combined general/epidural (G/E)
Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery
Intervention: Epidural Anaesthesia
Outcomes
Primary Outcomes
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period
Time Frame: 60 months
The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them Arrhythmias observed: tachycardia \>100 bpm bradycardia \< 50 bpm pause (P-P interval \> 2 seconds) ventricular extrasystoles (VE) \> 1000/ 24 hours supraventricular extrasystoles (SVE) \>200/24 hours
Secondary Outcomes
- The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed(60 months)